Large Pharmaceutical Company
- Sponsor utilizing CRO for global Clinical Monitoring support
- CRO monitoring team had high turnover rate > 30%, inexperienced CRAs and 2 Project Managers assigned within 4 months due to turnover.
- Need to contain costs in monitoring force.
- Sponsor engaged KPS to perform QC Assessment Evaluation of active studies
- KPS completed 60 monitoring oversight visits in Europe, South America, and North America in five (5) months
- All QC Monitoring Reports delivered to Sponsor outlining required next steps
monitoring oversight visits around the world
- Remediation plans implemented to clean up backlogged studies
- KPS deployment of Global Monitoring & Oversight Program
- In Jan 2015, new KPS CRAs hired and existing vendor monitors re-badged and deployed under KPS Management